Soluble fas urinary marker for the detection of bladder transitional cell carcinoma

Abstract

The present invention is an apparatus, system and method for detecting bladder cancer are provided that includes a substrate including one or more sFas binding agents and one or more reagents that indicate the amount of sFas present in the sample.

1. A method of screening for bladder cancer in a patient comprising the steps of:
 contacting a urine sample from the patient with a component of a standard assay method that detects an sFas protein, wherein the standard assay method comprises an enzyme assay, enzyme-linked immunosorbent assay; immunoassay, radioassay, competitive binding assay and combinations thereof; and 
 quantifying the amount of the sFas protein in the urine sample, wherein the presence of sFas is indicative of bladder cancer cells. 
 
     
     
       2. The method of  claim 1 , wherein the patient is currently or previously treated for bladder cancer. 
     
     
       3. The method of  claim 1 , wherein the standard assay method uses a detectable label capable of generating a measurable signal. 
     
     
       4. A non-invasive method for facilitating diagnosis of a subject for a bladder cancer, comprising:
 obtaining a urine sample from the subject; 
 quantifying the presence of an sFas protein in the urine sample; and 
 comparing the quantity of the sFas protein to a standard, wherein the quantity of the sFas protein is indicative of the presence of bladder cancer. 
 
     
     
       5. The method of  claim 4 , wherein subject has previously been treated surgically or hormonally. 
     
     
       6. The method of  claim 4 , wherein the sFas is quantified by an immunochemical assay, by a radio-immune assay, by an enzyme-linked immunosorbant assay, an ELISA assay or combination thereof. 
     
     
       7. A method of screening for intermediate-grade or high-grade bladder cancer in a patient, said method comprising the steps of:
 obtaining a urine sample from the subject; 
 quantifying the presence of an sFas protein in the urine sample; and 
 comparing the quantity of the sFas protein to a standard, wherein the quantity of the sFas protein is indicative of the presence of bladder cancer. 
 
     
     
       8. A method for detecting a recurrence of bladder cancer in a subject, the method comprising the steps of:
 obtaining a urine sample from the subject; 
 quantifying the presence of an sFas protein in the urine sample; and 
 comparing the quantity of the sFas protein to a standard, wherein the quantity of the sFas protein is indicative of the presence of bladder cancer. 
 
     
     
       9. A method for detecting bladder cancer in a subject, the method comprising the steps of:
 obtaining a urine sample from the subject; and 
 detecting an sFas protein in the urine sample, wherein an increase in the level sFas protein in urine when compared to normal subjects is indicative of a bladder cancer of intermediate grade or greater. 
 
     
     
       10. The method of  claim 9 , wherein the patient is currently or previously treated for bladder cancer. 
     
     
       11. The method of  claim 9 , wherein the standard assay method uses a detectable label capable of generating a measurable signal. 
     
     
       12. The method of  claim 9 , wherein subject has previously been treated surgically or hormonally. 
     
     
       13. The method of  claim 9 , wherein the sFas is quantified by an immunochemical assay, by a radio-immune assay, by an enzyme-linked immunosorbant assay, an ELISA assay or combination thereof. 
     
     
       14. The method of  claim 9 , wherein a significant increase in sFas in urine is indicative of bladder cancer that is grade Tis, Ta or greater. 
     
     
       15. The method of  claim 9 , wherein an increase in a previously detected level of the sFas in urine from a patient with grade Tis or Ta bladder cancer is indicative of bladder cancer that has progressed to grade T1 or greater. 
     
     
       16. The method of  claim 9 , wherein an increase in the level of the sFas detected in urine from when the bladder cancer was level Tis or Ta is indicative of bladder cancer that is invasive.